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目的:建立雷公藤口服液中雷公藤甲素、总二萜内酯以及总生物碱的含量测定方法,为质量控制提供依据。方法:采用高效液相色谱(HPLC)法,Eclipse XDB-C18色谱柱(150 mm×4.6 mm,5μm),以乙腈-水为流动相进行梯度洗脱,流速1.0 ml·min~(-1),柱温40℃,检测波长218 nm,测定雷公藤口服液中雷公藤甲素的含量。采用紫外可见分光光度法,分别以雷公藤甲素、雷公藤次碱为对照,测定雷公藤总二萜内酯、总生物碱的含量。结果:雷公藤甲素、总二萜内酯(以雷公藤甲素计)和总生物碱(以雷公藤次碱计)的线性关系良好(r≥0.999 8),平均加样回收率分别为91.96%、90.73%、99.18%,RSD均小于3%。结论:本研究所建立的方法稳定可靠,重复性良好,可用于雷公藤口服液的质量控制。
OBJECTIVE: To establish a method for the determination of triptolide, total diterpene lactone and total alkaloids in triptolide oral solution and to provide the basis for quality control. Methods: The gradient elution was carried out with a mobile phase of acetonitrile-water using a high performance liquid chromatography (HPLC) on a Eclipse XDB-C18 column (150 mm × 4.6 mm, 5 μm) with a flow rate of 1.0 ml · min -1 , Column temperature 40 ℃, detection wavelength 218 nm, determination of triptolide oral triptolide content. The contents of total diterpene lactones and total alkaloids in Tripterygium wilfordii were determined by UV-Vis spectrophotometry with triptolide and tripterygium wilfordii respectively as controls. Results: The linear relationship between triptolide, total diterpene lactone (calculated as triptolide) and total alkaloids (calculated as triptolide) was good (r≥0.999 8), and the average recoveries were 91.96%, 90.73%, 99.18%, RSD less than 3%. Conclusion: The method established in this study is stable and reliable with good reproducibility and can be used for quality control of triptolide oral solution.